Drug delivery via ocular implant

ABSTRACT

A method and apparatus for administering an active agent such as a medicine to a subject, uses an ocular implant such as a punctal plug, to which the active agent has been applied. The implant is installed at the eye of the subject for administering the active agent via tissues of the eye.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No. 10/825,047, entitled “DRUG DELIVERY VIA OCULAR IMPLANT,” filed on Apr. 15, 2004, the specification of which is incorporated herein in its entirety by reference.

TECHNICAL FIELD

The present invention relates generally to the field of medicine, and in particular to a new and useful method and apparatus for administering an active agent, i.e. a medicine or medication, to a subject by transdermal or other surface absorption of the agent into the tissues in and around one or both eyes of the subject.

BACKGROUND

Punctal plugs are known which are made in suitable dimensions and of suitable materials to be removably inserted into the upper and/or lower punctal apertures or punctum of the eye, to block the opening and the canaliculus communicating therewith, to prevent drainage of lacrimal fluid (tears). Such plugs are known to be made of suitable materials, such as polymers, for example polytetrafluoroethylene (known by the trademark TEFLON), or hydroxyethylmethacrylate (HEMA), hydrophilic polymer, methyl methacrylate, or silicon, or even of stainless steel or other inert metal material.

It is also known to apply an active agent such as nicotine or a birth control drug, to the inner surface of a patch which can be worn against the skin of a subject for transdermally administering the active agent to the subject.

SUMMARY

It is an object of the present invention to provide a method and an apparatus for administering an active agent to a subject by applying the active agent to at least one surface of an ocular implant such as a punctal plug, and installing the implant, e.g., inserting the punctal plug into a punctal aperture of the subject.

If the active agent or drug is meant for treating the tissues at the walls of the canaliculus, for example, the drug is applied only to inner surfaces of the plug that are adapted to be in contact with or near the tissues of the canaliculus. The presence of tears is highly advantageous as a natural vehicle or carrier for the agent.

If the active agent or drug is meant for treating the eye itself, the drug is applied only to outer surfaces of the implant or plug that are adapted to be outside the canaliculus. Here the presence of previously secreted tears or a tear pool is again advantageous as a natural vehicle or carrier for the agent.

Any or all surfaces of the implant may carry the active agent there the desire is simply to have the agent enter the subjects blood stream via the tissues in and around the eye.

The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which preferred embodiments of the invention are illustrated.

These and other examples, aspects, advantages, and features of the implants described herein will be set forth in part in the Detailed Description, which follows, and in part will become apparent to those skilled in the art by reference to the following description of the present leads and methods, and drawings or by practice of the same.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numerals describe similar components throughout the several views. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in this patent document.

FIG. 1 is a schematic perspective view of an ocular implant in the form of a punctal plug, as constructed in accordance with at least one embodiment of the invention.

FIG. 2 is a perspective view of the area around the eye with other embodiments of the invention.

DETAILED DESCRIPTION

Referring now to the drawing, FIG. 1 shows a punctal plug generally designated 10, having a stem 12 for insertion into the punctal aperture 20 of an eye 24, and along the canaliculus 22 communicating with the aperture.

Plug 10 has a large stopper structure 14 connected to the outer end of stem 12 for seating against the aperture 20 and sealing the canaliculus 22 against the flow of tears onto the surface of the eye or eyeball 24.

FIG. 2, where the same of similar numerals are used to designate functionally similar parts, illustrates an eye 24 communicating with upper and lower canaliculi 22 a and 22 b, each with their our implant 10 a and 10 b. Implant 10 a is a substantially cylindrical and solid collagen plug that has been inserted into the upper punctum or tear duct 20 a, to block the flow of tears while lower implant 10 b is hollow like a straw for the passage of tears. Implant 10 b includes a tapered shaft or stem 12 a with a flared open end 12 b immobilized at the lower punctum 20 b. A mushroom shaped inner stopper 14 a is formed at the opposite end of shaft 12 a for further setting the location of the implant in the tear duct.

One of the embodiments illustrated in FIG. 2, e.g., the upper implant, may include a hollow core of the plug and another, e.g., the lower one, may include a hollow core filled with medication.

The active agent, e.g., a medicine or medication is applied, e.g., in one or more bands of polymer material 16 at the inner end of the stem, or at 18 on the outer end of the stopper 14 in the embodiment of FIG. 1, or over some or all of the surfaces of the implants of FIG. 2, or otherwise. Polymer that is absorbent to the agent is preferable so that sufficient agent is present and available for discharge into the surrounding tissues. A porous or absorbent material can alternatively be used to make up the entire plug or implant which can be saturated with the active agent.

The hollow implant 10 b of FIG. 2 is also particularly useful in that the active agent can be applied to, or is otherwise available at the inner surface or interior of the implant, and is uniquely structured to pass tears and thus administer the active agent to the tear stream in a fashion that is controlled by the flow of tears which thus act as the carrier for the agent. Unlike the usual tear stopping punctal plug, the hollow implant of the present invention provides a very different drug administering method, scheme and structure.

Non-limiting examples of the active agents or medications which are appropriate for use with the invention include, for example only: topical prostaglandin derivatives such as latanoprost, travaprost and bimataprost used for the topical treatment of glaucoma. Also a treatment for corneal infections is appropriate using ciprofloxacin, moxifloxacin or gatifloxacin. Systemic medications useful for this invention are those used for hypertension such as atenolol, nifedipine or hydrochlorothiazide. Any other chronic disease requiring chronic medication could be used.

The treatment of allergic conjunctivitis and rhinitis are also good applications for the invention, e.g., using antihistamine and anti-allergy medication such as olopatadine and cromalyn sodium in or on the implant.

The advantage is that there would be no need for chronic pill-taking or drop taking. A once-per 3-6 month visit to the eye doctor would be all that is needed. Also the issue of non-compliance, a major impediment to successful treatment, would by avoided by the invention.

This list of active agents is not comprehensive in that many other agents can be used with the present invention. For example, a treatment for dry eye bytopical cyclosporin is particularly interesting for administration by the present invention, but many other active agents can also be administered using the method and apparatus of the invention.

The invention is meant to embody all implants or devices which are implanted into the eye-lid canalicular puncta of the naso-lacrimal system with the goal of delivering drug to the eye or to the body.

The implant is inserted into either the inferior (lower) or superior (upper) punctum or possibly both. The apparatus is constructed so as to have a drug attached to one or both sides of the implant and an occlusive plug of some inert biocompatible material.

Depending on the desired therapy, the implant could be oriented in the punctal canal to deliver the drug either to the tear lake and thus the eye, or to the nasolacrimal system and thus the body's systemic circulation. The drawings illustrate only three embodiments of the punctal plug or implant delivery system of the invention.

While a specific embodiment of the invention has been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles.

In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, apparatus, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

The Abstract is provided to comply with 37 C.F.R. §1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. 

1. An ocular implant comprising: an implant body partially defined by a first end portion and a second end portion, the implant body including a hollow portion extending the length of the implant body, the hollow portion configured to allow for the passage of tear fluid therethrough; and an active agent.
 2. The ocular implant of claim 1, wherein the hollow portion includes a straw-like configuration.
 3. (canceled)
 4. The ocular implant of claim 1, wherein the active agent includes at least one of a topical prostaglandin, latanoprost, travaprost, bimataprost, a medication for the treatment of corneal infections, ciprofloxacin, moxifloxacin, gatifloxacin, a systemic medication, a medication for treating hypertension, atenolol, nifedipine, hydrochlorothiazide, cyclosporine, or olopatadine.
 5. The ocular implant of claim 1, wherein the active agent includes at least one of an antihistamine, an anti-allergy medication, olopatadine, or cromalyn sodium.
 6. The ocular implant of claim 1, wherein the active agent includes a chronic medication.
 7. The ocular implant of claim 1, wherein the implant body extends from the first end portion, configured to seat at or near a lacrimal punctum when implanted, to the second end portion, configured for insertion through the lacrimal punctum into a lacrimal canaliculus when implanted, the first end portion including an opening configured to direct tear fluid into the hollow portion.
 8. The ocular implant of claim 1, wherein the hollow portion is substantially parallel or concentric with an axis of the implant body.
 9. The ocular implant of claim 1, wherein the hollow portion is at least partially filled with a second material.
 10. The ocular implant of claim 9, wherein the second material includes the active agent.
 11. The ocular implant of claim 1, wherein the implant body is formed of a porous or absorbent material.
 12. The ocular implant of claim 11, wherein the porous or absorbent material of the implant body is saturated with the active agent.
 13. The ocular implant of claim 1, wherein the active agent is made available at an interior of the hollow portion.
 14. An ocular implant comprising: an implant body extending from a proximal end, configured to seat against a punctal aperture, to a distal end, configured to insert into the punctal aperture, and including a hollow portion, the hollow portion extending from the proximal end to the distal end and configured for a passage of tear fluid therethrough; and an active agent disposed in or on one or more portions of the implant body or the hollow portion, the active agent deliverable on a sustained release basis to tissue at or near at least one of an eye or a nasolacrimal system of a subject.
 15. The ocular implant of claim 14, wherein the active agent is made available at an interior of the hollow portion and is configured to leave the implant body with the passage of tear fluid, when implanted.
 16. The ocular implant of claim 15, wherein the sustained release of the active agent to tissue at or near the nasolacrimal system of the subject is via the interior of the hollow portion.
 17. The ocular implant of claim 14, wherein the implant body is configured to provide the sustained release of active agent to tissue for a time period between 3-6 months, after implant.
 18. The ocular implant of claim 14, wherein the entire implant body is saturated with the active agent.
 19. The ocular implant of claim 14, wherein the active agent is configured to deliver medication, at least in part, to the nasolacrimal system.
 20. The ocular implant of claim 14, wherein the active agent is configured to treat glaucoma of the eye.
 21. A method comprising: placing an ocular implant, including a hollow portion extending therethrough, adjacent an eye of a subject; and administering an active agent, applied to the ocular implant, to tissue of one or both of the eye or a nasolacrimal system.
 22. The method of claim 21, comprising allowing tear fluid to flow through the hollow portion of the ocular implant.
 23. The method of claim 21, comprising treating at least one of glaucoma, a corneal infection, allergic conjunctivitis or rhinitis.
 24. The method of claim 21, wherein administering the active agent includes transdermal or surface absorption of the active agent into the tissue of the eye.
 25. The method of claim 21, wherein administering the active agent includes administering the active agent to tissue at one or more walls of a lacrimal canaliculus.
 26. The method of claim 25, wherein administering the active agent to the one or more walls of the lacrimal canaliculus includes systemically delivering the active agent to the subject.
 27. The method of claim 21, wherein administering the active agent includes using tear fluid as a carrier for the active agent from the ocular implant to tissue of the eye or the nasolacrimal system.
 28. The method of claim 21, wherein administering the active agent includes providing a sustained agent release for a time period between 3-6 months after implant. 